BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4110780 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27936
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 24, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN PUMP WAS ALARMING NO DELIVERY. CUSTOMER VERIFIED CONNECTION BETWEEN THE RESERVOIR AND INFUSION SET WAS SECURE. CUSTOMER STATED NOT STRAIN AND INFUSION SET IS NOT BENT OR KINKED. DURING TROUBLESHOOTING, CUSTOMER WAS ASKED TO PERFORM A FIXED PRIME OF INSULIN. CUSTOMER STATES THE INSULIN DID EXIT. NEXT, CUSTOMER WAS ASKED TO MANUAL PRIME OF INSULIN. CUSTOMER STATES THE INSULIN DID EXIT AND DEVICE DID NOT ALARM. ADVISED CUSTOMER DEVICE IS FUNCTIONING AS DESIGNED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 143 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589896 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC MINIMED MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR